| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
August 8, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11 - 41
Richard R. Martin
President and Owner
Sivertson Fisheries Inc. dba Lake Superior Fish Company
1507 North First Street
Superior, Wisconsin 54880
Dear Mr. Martin:
We inspected your seafood processing facility located at 1507 North First Street, Superior, Wisconsin, on May 4-6, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 and 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your pickled herring and air-packed, ready-to-eat smoked fish products and your raw trout, whitefish, herring, and walleye fillets are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards and Controls Guidance through links on FDA’s home page at www.fda.gov.
Your significant violations are as follows:
1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). Your firm did not monitor exclusion of pests from the food plant with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by:
â–º pest control reviews reveal 10 mice have been captured in the facility noted between 1/11-3/11;
â–º dead mice were observed in the facility;
â–º what appeared to be dead insects were observed scattered in various processing and non-processing areas.
2. Your firm did not monitor conditions and cleanliness of food contact surfaces to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 in a timely manner as evidenced by: on 5/4/11 two of the (b)(4) smelt dressing machines were observed to have debris on the conveyor lines. The last processing date for these machines was 4/28/11. Additionally, on 5/4/11 one smelt dressing machine loading tray was observed with caulking which appeared to be peeling and had rough edges.
3. You must correct in a timely manner sanitation deficiencies that you detect during monitoring, to comply with 21 CFR 123.11(b). However, your firm did not adequately correct controls to exclude pests from your facility, as evidenced by repeated FDA 483 Observations of the presence of pests. Our investigator observed conditions illustrating that you have failed to correct points of possible entry; failed to eliminate harborage areas, including clutter, old equipment and debris inside and outside your facility; and failed to maintain equipment in a manner to avoid attraction of pests as evidenced by the remains of food debris on inactive equipment.
4. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for trout, whitefish, herring, and walleye fillets does not list the following food safety hazards:
â–º Clostridium botulinum in the frozen vacuum-packaged products. Please refer to Chapter 13 of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazard Guide) for information on the labeling of frozen vacuum-packaged fish products to ensure adequate handling by the end user;
â–º Scombrotoxin (histamine) formation in the herring products. Please refer to Chapter 7 of the Hazard Guide for information related to control of scombrotoxin (histamine) formation in scombroid species of fish;
â–º Undeclared allergens. These products pose a hazard for allergens based on the presence of the fish proteins. Please refer to Chapter 19 of the Hazard Guide for additional information related to the hazard of undeclared allergenic substances.
5. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s HACCP plan for “Smoked Fish & Pickled Fish” does not list critical limits at the receiving critical control point adequate to control pathogen growth and histamine formation. Specifically, the listed critical limit of “check temp (b)(4)ºF or below” is not adequate because a one time temperature check is only appropriate when transit times are short (i.e., less than four hours). Consequently, your firm must ensure that the products are, in fact, only in transit for this short duration. FDA recommends that for refrigerated products that are in transit for four hours or less, the critical limits at receiving include both a temperature limit and the date and time the products were removed from a controlled temperature environment and the date and time of delivery. Please refer to Chapter 12 of the Hazard Guide for additional information related to control of pathogen growth in refrigerated products. Please refer to Chapter 7 for information on control of scombrotoxin (histamine) formation.
6. Because you chose to include corrective action plans in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your smoked fish and pickled fish products at the receiving and storage critical control points are not adequate to control pathogen growth and histamine. Specifically, your plans do not address correcting the cause of the deviations.
Please note that the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazard Guide) may be found on our web site at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
Seafood/FishandFisheriesProductsHazardsandControlsGuide/default/htm.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Compliance Officer Demetria L. Lueneburg at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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